Quality Smart Solutions ensures your labels meet DSHEA and 21 CFR code of federal regulations. We review your labels, advise on structure-function claims, prepare a substantiation dossier (if required) and file a pre-market notification with FDA . We guide you to market your products, and stay compliant with FDA regulations.
Dietary supplements are health and wellness products that contain dietary ingredients, including minerals, vitamins, herbs, amino acids, botanicals, and other categories of ingredients that can be used to supplement diets. The forms of dietary supplements include but are not limited to tablets, powders, capsules, gummies and liquids. The supplements are used to improve health, used for prevention of ailments and and for the maintenance of overall wellness.
Based on the CRN Consumer Survey on Dietary Supplements conducted in 2019, 77% of Americans consume dietary supplements. The majority of both are males and females, aged 18+ years. Among the age groups, adults between the ages of 35 – 54 years share 18% consumption, the highest usage of dietary supplements. Consequently, the nutritional supplement industry is witnessing massive growth, primarily in vitamins and protein supplements.
FDA governs Dietary Supplements. FTC governs the marketing and advertisement of dietary supplements. Failure to comply with the regulations can result in FDA warning letter issuance, FTC fines, stop sale, recall and potential litigation. If you exporting dietary supplements to the United States it may result in entry refusal and the U.S. Customs and Border Protection detaining your goods. As a manufacturer, importer, or distributor of dietary supplements and dietary ingredients, you’re solely responsible for assessing the safety and labeling of your products. You must ensure products adhere to all the requirements of FDA and DSHEA regulations. Here are a list of requirements to keep in mind for your dietary supplement.
Proven Expertise. Companies who have Trusted Us to Become Regulatory Compliant with FDA
I have been working with Andrew and his team at QSS for a couple of years now. I have clients from many different parts of the world and each situation requires expertise and focus, which I’m getting from QSS. I highly recommend Andrew and QSS to any perspective client who wants to “get it right” regarding Canadian and cross border compliance.
We have reviewed a wide range of Dietary Supplement Product Labels, including but not limited to the following.
Our team consists of professionals who have extensive FDA Dietary Supplement, Food, Pharma, Medical Device, and Drug regulatory, licensing experience having reviewed over 1500 dietary supplement labels.
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Inspection of your food facility will help identify and fix any quality or processing deviations found regarding food safety. Review of the processes and procedures... Read more
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